Claims for Patent: 9,193,782

Summary for Patent: 9,193,782

Title:	Use of the SPARC microenvironment signature in the treatment of cancer
Abstract:	The invention provides multiparametric anti-SPARC antibody-based techniques for predicting the response to chemotherapy.
Inventor(s):	Trieu; Vuong (Agoura Hills, CA), Liu; Xiping (Temple City, CA), Desai; Neil (Los Angeles, CA)
Assignee:	Abraxis BioScience, LLC (Los Angeles, CA)
Application Number:	13/153,187
Patent Claims:	1. A method of treating a human patient with a breast tumor exhibiting a SPARC microenvironment signature comprising: (a) preparing a plurality of histological sections of the tumor to obtain a SPARC microenvironment signature by immunostaining a histological sections of the tumor with a first anti-SPARC antibody, wherein the first anti-SPARC antibody binds to the immunodominant epitopes bound by the anti-SPARC polyclonal antisera AF941, and immunostaining histological sections of the tumor with a second anti-SPARC antibody, wherein the second anti-SPARC antibody binds to the epitope bound by the anti-SPARC monoclonal antibody Mab941; (b) selecting a patient with a breast tumor having a SPARC microenvironment signature of least 70% of the tumor cells, fibroblasts, blood vessels, stroma and inflammatory cells staining positive with the first antibody, and at least 50% of the inflammatory cells and at least 70% of the blood vessels and stroma staining positive with the second antibody; and (c) administering a therapeutically effective amount of a chemotherapeutic regimen to the selected patient. 2. A method of treating a human patient with a breast tumor exhibiting a SPARC microenvironment signature comprising: (a) preparing a plurality of histological sections of the tumor to obtain a SPARC microenvironment signature by immunostaining a histological sections of the tumor with a first anti-SPARC antibody, wherein the first anti-SPARC antibody binds to the immunodominant epitopes bound by the anti-SPARC polyclonal antisera AF941, and immunostaining histological sections of the tumor with a second anti-SPARC antibody, wherein the second anti-SPARC antibody binds to the epitope bound by the anti-SPARC monoclonal antibody Mab941; (b) selecting a patient with a breast tumor having a SPARC microenvironment signature of least 60% of the tumor cells, blood vessels, and stroma staining positive with the first antibody, and at least 60% of the tumor cells staining positive with the second antibody; and (c) administering a therapeutically effective amount of a chemotherapeutic regimen to the selected patient. 3. The method of claim 1 or 2, wherein the tumor is a Her2 positive breast cancer and wherein the chemotherapeutic regimen comprises six cycles of: (a) neoadjuvant nab-paclitaxel at 125 mg/m2 on days 1, 8, 15 of each 28 day cycle, (b) carboplatin AUC6 on day, 1 of each 28 day cycle, (c) trastuzumab with a 4 mg/kg load followed by 2 mg/kg/week, and (d) bevacizumab at 5 mg/kg/week, followed by surgical removal of the primary tumor, followed by therapeutically effective amounts of trastuzumab and bevacizumab for 52 weeks. 4. The method of claim 1 or 2, wherein the tumor is a Her2 negative breast cancer and wherein the chemotherapeutic regimen comprises (a) preoperative therapy comprising 6 cycles of 14 days with nab-paclitaxel (175 mg/m.sup.2), gemcitabine (2000 mg/m.sup.2), and epirubicin (50 mg/m.sup.2) and (b) postoperative therapy comprising 4 cycles of 14 days with nab-paclitaxel (220 mg/m.sup.2) and gemcitabine (2000 mg/m.sup.2). 5. The method of claim 1, wherein the first anti-SPARC antibody is the polyclonal antisera AF91 and the second anti-SPARC antibody, is the monoclonal antibody Mab 941. 6. The method of claim 2, wherein the first anti-SPARC antibody is the polyclonal antisera AF91 and the second anti-SPARC antibody, is the monoclonal antibody Mab 941.

Details for Patent 9,193,782

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	09/25/1998		2030-06-03
Genentech, Inc.	HERCEPTIN	trastuzumab	For Injection	103792	02/10/2017		2030-06-03
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	02/26/2004		2030-06-03
Genentech, Inc.	HERCEPTIN HYLECTA	trastuzumab and hyaluronidase-oysk	Injection	761106	02/28/2019		2030-06-03